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临床试验/NCT01410149
NCT01410149已完成不适用

The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Sleep quality

研究概览

简要总结

Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75
  • received mechanical ventilation >72 hours
  • glasgow coma scale >10
  • acute physiology score <13
  • ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio >200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
  • sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
  • anticipate ongoing need for partial ventilatory support for the following 72 hours

排除标准

  • Successful completion of spontaneous breathing trial
  • Neurological injury, encephalopathy or abnormal EEG
  • History of central sleep apnea
  • General anaesthesia within 72 hours from study entry
  • Requiring haloperidol >10 mg/24 hours
  • hemodynamically unstable

结局指标

主要结局

Sleep quality

时间窗: 3 nights

Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

次要结局

  • Patient-ventilator asynchrony(3 nights)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Bosma

Principal Investigator

Lawson Health Research Institute

研究点 (2)

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